SHERIDAN, WYOMING – May 27, 2025 – Roche has announced an encouraging update on its supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx), following discussion by the FDA’s Oncologic Drugs Advisory Committee (ODAC). The combination therapy demonstrated a significant 41% reduction in the risk of death in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not candidates for autologous stem cell transplant.
Landmark survival data in STARGLO trial supports regulatory momentum
The phase III STARGLO trial marked a first in the field by showing a statistically significant and clinically meaningful survival advantage in R/R DLBCL. The study enrolled 274 patients across 62 sites in 13 countries, including the US, with the majority of patients based outside Asia. Importantly, Roche emphasized that the patient characteristics closely mirror those seen in the US, strengthening the applicability of the data.
Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, stated:
“Columvi in combination with GemOx demonstrated a 41% reduction in risk of death in a phase III, randomised, multiregional clinical trial, supporting its recent approval by the European Commission and inclusion in the US National Comprehensive Cancer Network treatment guidelines as a category 1 preferred regimen. We believe the STARGLO results are applicable to US patients, with the global study population closely mirroring the real-world clinical profile of DLBCL patients in the US, and we will continue working with the FDA on the regulatory path forward.”
Transforming care for transplant-ineligible patients
The Columvi-GemOx regimen addresses a pressing clinical gap: around 75% of US patients with R/R DLBCL are unable to receive or tolerate transplant or cutting-edge cell therapies. The off-the-shelf, fixed-duration nature of Columvi offers a potential game-changer for community-based oncology settings.
Dr. Krish Patel, Director of Lymphoma Research at the Sarah Cannon Research Institute, added:
“Many of the patients with DLBCL who I see in my clinic are similar to the patients reflected in this study, making the glofitamab-GemOx regimen an important potential treatment option. These patients need more effective, readily available treatment options and the compelling results from STARGLO deliver on this need.”
Key efficacy and safety outcomes from STARGLO
- Overall survival: 41% risk reduction compared to rituximab-GemOx (HR=0.59, p=0.011)
- Progression-free survival: 63% risk reduction (HR=0.37, p<0.0001)
- Median overall survival: 25.5 months with Columvi-GemOx vs. 12.9 months with rituximab-GemOx
- Safety profile: Adverse events were consistent with individual medicines; cytokine release syndrome was mostly low-grade and occurred primarily in Cycle 1
The higher median number of cycles (11 vs. 4) observed in the Columvi arm reflects better disease control. Two-year follow-up data will be presented at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting.
Strategic inclusion in NCCN guidelines and global uptake
Columvi in combination with GemOx is now approved in over 30 countries and was recently designated a Category 1 preferred regimen in the NCCN Guidelines® for second-line treatment in transplant-ineligible DLBCL. The STARGLO study is positioned to confirm and potentially convert Columvi’s accelerated US approval into full FDA approval, with a decision expected by July 20, 2025.
Roche’s broader haematology vision
The Columvi update reinforces Roche’s long-term commitment to haematology innovation. Its portfolio includes pioneering therapies such as Polivy®, Lunsumio®, and Venclexta®, alongside an advanced pipeline exploring next-generation T-cell engaging antibodies. This latest progress aligns with Roche’s strategic goal to redefine treatment paradigms in earlier disease stages to drive durable remissions and improved patient outcomes.
Learn more about Roche’s haematology innovations at www.roche.com.